Yoga for Veterans With CLBP

Chronic Low Back Pain Clinical Trial

Official title:

Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524158
• Other study ID #: O7768-R
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: September 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 31, 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has a VA primary care provider

• Diagnosis of chronic low back pain > 6 months

• Willing to attend a yoga program or be assigned to delayed treatment with yoga

• Willing to complete 4 assessments

• English Literacy

• Has not begun new pain treatments or medications in the past month

• Willing to not change pain treatments (e.g., discontinue a treatment; increase medication dose) during the 12-week intervention period unless medically necessary

Exclusion Criteria:

• back surgery within the last 12 months

• back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia)

• morbid obesity (BMI > 40)

• Significant sciatica or nerve compression < 3 months or chronic lumbar radicular pain > 3 months

• Unstable, serious coexisting medical illness (eg, CHF, cancer, COPD, morbid obesity; dementia)

• Unstable, serious psychiatric illness (e.g., unmanaged psychosis, active substance dependence)

• Insufficient data to rule out acute, metastatic disease, (unless primary care physician approves)

• Attended or practiced yoga > 1x in the last 12 months

• Positive Romberg test (with or without sensory neuropathy)

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• Yoga Therapy for CLBP
Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland-Morris Disability Questionnaire	The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.	baseline to 12 weeks
Primary	Roland-Morris Disability Questionnaire	The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.	baseline to 6-months
Secondary	Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks	The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.	baseline to 12 weeks
Secondary	Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months	The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.	baseline to 6 months
Secondary	Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks	The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 7 interference items used a as a measure of pain interference. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.	baseline to 12 weeks
Secondary	Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks	Fatigue (absence of energy) will be measured with the Fatigue Severity Scale (FSS). The FSS is a self-administered instrument developed to assess the impact and severity of fatigue. It consists of 9 items describing the functional impact of fatigue on daily life rated on a scale from 1 (strongly disagree) to 7 (strongly agree) with the total fatigue score ranging from 9-63 or an average score ranging from 1.0-7.0. Higher scores reflect greater fatigue severity and less energy.	baseline to 12 weeks
Secondary	Change From Baseline - SF12 PCS at 12 Weeks	Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.	baseline to 12 weeks
Secondary	Change From Baseline - SF12 MCS at 12 Weeks	Mental Component Scale - Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.	baseline to 12 weeks
Secondary	Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks	The EQ5D is a preference-based measure of health-related quality of life. The measure produces a single score ranging from 0 (death) to 1.00 (optimal health). Scores can be integrated with time to calculate Quality Adjusted Life Years.	baseline to 12 weeks
Secondary	Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks	Depression will be assessed using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Derived from the full CES-D, there are 10 items that ask about the frequency of mood symptoms, rated on a 4-point Likert scale ranging from 0 (Never) to 3 (All of the Time). Scores range from 0 to 30, and higher scores indicate greater depression. A number of items are reverse-scored and a score of 10 or greater is considered depressed. Normative data on people with assorted chronic illnesses are available for comparisons.	baseline to 12 weeks
Secondary	Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks	The Brief Anxiety Inventory (BAI) measures the severity of anxiety symptoms, particularly those that distinguish anxiety from depression. The BAI consists of 21 items, is self-administered and can be completed in 5 to 10 minutes. Items are scored on a scale of 0 to 3 and are summed to generate a total score. Scores range from 0 to 63, and higher scores indicate greater depression.	baseline to 12 weeks
Secondary	Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks	The PSQI is a validated measure of sleep quality. The global PSQI score has a range of 0-21, with higher scores indicating worse sleep quality.	baseline to 12 weeks
Secondary	Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks	Self-efficacy for controlling CLBP reflects levels of confidence in the ability to influence the intensity of back pain symptoms and the impact that CLBP has on daily life. The questions are based on self-efficacy items developed for the Medical Outcomes Study in mixed chronic diseases. The wording of the items has been adapted to be specific to CLBP. The measure consists of 6 items, rated on a 6-point Likert scale, with each item ranging from 0-10. The total score is the mean of the 6 items with higher scores indicating greater self-efficacy for managing CLBP.	baseline to 12 weeks
Secondary	Attendance/ Home Practice	Two indicators of the amount of yoga practiced by each participant will be used. Actual attendance of yoga sessions will be assessed using VA medical record data. Attendance can range from 0-24 sessions attended for those participants randomized to yoga. Self-reported practice of yoga at home will be assessed using a weekly participant yoga log. The self-report yoga log assesses whether they practiced yoga each day, the amount of minutes practiced, the use of instructions, the difficulty of poses, and the estimated level of physical activity or exertion.	12 weeks
Secondary	Change From Baseline - Range of Motion - Flexion at 12 Weeks	Spinal Range of Motion (ROM) will be measured using a Saunders Digital Inclinometer, a portable device which isolates lumbar ROM. The device is placed along the spine and uses a precise optical angular scanner. Forward bend angle measures how far forward and downward a person can bend at the waist, from a fully erect and/or normal standing position. The value typically ranges from 0-180 degrees, with higher values indicating greater flexibility.	baseline to 12 weeks
Secondary	Change From Baseline - Grip Strength at 12 Weeks	Grip strength in both hands of each participant will be measured using an adjustable, hydraulic grip strength dynamometer (Jamar Hydraulic Hand Dynamometer). Three trials will be conducted for each hand. In cases of current pain flare-ups or recent procedures to a hand or wrist, the affected hand is not tested, and the result of the one other hand is used. If both hands are used the best performance of two trials will be selected for each side, and the average of the left and right hand will be used for analysis. The value measured is pounds of force exerted and typically ranges from 0 - 150 lbs, with higher numbers indicating greater grip strength.	baseline to 12 weeks
Secondary	Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks	The Single Leg Stance (SLS) is a commonly used measure of both lower leg strength and balance. A total of four trials were conducted - left and right leg with both eyes open and eyes closed. Each trial will be timed from the moment the participant lifts one foot off the floor until the moment they need to place it on the floor again. If the participant is able to stand on one leg for 60 seconds the trial will be stopped and they will be asked to switch side. Values range from 0 - 60 seconds with greater values indicating better balance.	baseline to 12 weeks
Secondary	Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks	Time in seconds holding plank position on the elbows.	baseline to 12 weeks